HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients

NCT05526339 | Unknown

• 1 other identifier: LY2022-018-A
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

Obesity is associated with adverse airway events including desaturation during deep sedation. Previous studies have suggested that high-flow nasal oxygenation may be superior to regular (low-flow) nasal cannula for prevention of hypoxia during Sedated Gastrointestinal Endoscopy in non-obesity patients. The prerequisite of high-flow nasal oxygenation is keeping airway patency. Our pervious study demonstrated that nasopharyngeal airway has the similar efficacy of jaw-lift. In present study we aimed to determine whether high-flow nasal oxygenation combined with nasopharyngeal airway could reduce the incidence of hypoxia during Sedated Gastrointestinal Endoscopy in obese patients.

Conditions

Gastric Cancer; Gastric Ulcer; Intestinal Cancer; Intestinal Polyps

Keywords

High-flow nasal oxygenation; Gastrointestinal endoscopy; Hypoxia

Outcome Measures

Primary Outcomes (1)

• The incidence of hypoxia

  Hypoxia refers to 75%≤SpO2\<90%,\<60S

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Secondary Outcomes (3)

• The incidence of severe hypoxia

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

• The incidence of subclinical respiratory depression

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

• The incidence of other adverse events

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Study Arms (2)

High-flow nasal oxygenation combined with nasopharyngeal airway

EXPERIMENTAL

High-flow nasal oxygenation combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol.

Device: High-flow nasal oxygenation combined with nasopharyngeal airway

Regular nasal cannula combined with nasopharyngeal airway

ACTIVE COMPARATOR

Regular nasal cannula combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol.

Device: Regular nasal cannula combined with nasopharyngeal airway

Interventions

High-flow nasal oxygenation combined with nasopharyngeal airway DEVICE

The patients receive an oxygen flow of 30 L/min for preoxygenation with a high-flow oxygenation device before losing of conscious. At the time of the abolition of the eyelash reflex, the gas flow was increased to 60 L/min with an inspired oxygen fraction 100% and the nasopharyngeal airway was placed.

High-flow nasal oxygenation combined with nasopharyngeal airway

Regular nasal cannula combined with nasopharyngeal airway DEVICE

The patients receive an oxygen flow of 6 L/min for preoxygenation with a regular nasal cannula until the end of procedure. At the time of abolition of the eyelash reflex, the nasopharyngeal airway was placed.

Regular nasal cannula combined with nasopharyngeal airway

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving selective combined upper intestinal and lower intestinal endoscopy procedure under deep sedation.
• Age ranging from 19 to 80, both male and female
• Obese patients，BMI ≥ 28kg/m\^2
• ASA I\~III
• Patients should clearly understand and voluntarily participate in the study, with signed informed consent.

You may not qualify if:

• Patients with acute respiratory infection in the last 2 weeks
• Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery
• hypoxia, defined as oxygen saturation measured by pulse oximetry (SpO2) ≤ 95% before preoxygenation.
• Common advanced gastrointestinal endoscopy procedures meeting eligibility criteria included cholangiopancreatography, endoscopic ultrasound procedures, endoscopic mucosal resection and endoscopic retrograde cholangiopancreatography (ERCP) procedures.
• coagulation disorders or platelets \< 100\*10\^9/L
• Have serious heart diseases such as severe arrhythmia, heart failure, Adams Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance \< 4mets
• Allergy to eggs, soy products, opioids and other drugs, propofol, etc.
• Participated in other clinical trials as a subject within 3 months
• Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc.
• Emergency procedure
• Pregnant or breast-feeding women
• Patients having procedures with planned tracheal intubation or laryngeal mask
• Investigator considers the patients are inappropriate to participate in this trial

Sponsors & Collaborators

• RenJi Hospital: lead
• Second Affiliated Hospital of Soochow University: collaborator
• Dushu Lake Hospital Affiliated to Soochow University: collaborator

Study Sites (2)

Dushu Lake Hospital Affiliated to Soochow University

Suzhou, Jiangsu, 215000, China

Location

Second Hospital Affiliated to Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Stomach Ulcer; Intestinal Neoplasms; Intestinal Polyps; Hypoxia

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Diansan Su

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diansan Su

CONTACT

+8618616514088; diansansu@yahoo.com

Lingke Chen

CONTACT

+8618601795041; www.clk@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: September 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)